Methods and Systems for Controlling Acoustic Energy Deposition Into A Medium

ABSTRACT

A method and system for acoustic treatment of tissue are provided. Acoustic energy, including ultrasound, under proper functional control can penetrate deeply and be controlled precisely in tissue. In some embodiments, methods and systems are configured for acoustic tissue treatment based on creating an energy distribution function in tissue. In some embodiments, methods and systems are configured based on creating a temperature distribution function in tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 61/506, 125, entitled “Systems and Methods for Creating Shaped Lesions” filed Jul. 10, 2011; U.S. Provisional Patent Application Ser. No. 61/506,127, entitled “Systems and Methods for Treating Injuries to Joints and Connective Tissue,” filed Jul. 10, 2011; U.S. Provisional Patent Application Ser. No. 61/506,126, entitled “System and Methods for Accelerating Healing of implanted Materials and/or Native Tissue,” filed Jul. 10, 2011; U.S. Provisional Patent Application Ser. No. 61/506,160, entitled “Systems and Methods for Cosmetic Rejuvenation.” filed Jul. 10, 2011; U.S. Provisional Patent Application Ser. No. 61/506,163, entitled “Methods and Systems for Ultrasound Treatment.” filed Jul. 10, 2011; U.S. Provisional Patent Application Ser. No. 61/506,609, entitled “Systems and Methods for Monitoring Ultrasound Power Efficiency,” filed Jul. 11, 2011; and U.S. Provisional Patent Application Ser. No. 61/506,610, entitled “Methods and Systems for Controlling Acoustic Energy Deposition into a Medium,” filed Jul. 11, 2011; all of which are incorporated by reference herein.

BACKGROUND

A variety of modalities exist to treat tissue, including mechanical means, lasers and other photon-based sources, radio frequency (RF) electrical currents, microwaves, cryogenic based techniques, and their various combinations, among others,

Each of these modalities has limitations which prevent a high degree of spatial control and precision during treatment, For example, in tissue the extreme absorption and scattering of photons relegates light based therapies to superficial applications that are tissue specific. Typically, electric currents, such as those emitted from a RF source, flow along the path of least impedance and are diffuse and non-selective, with maximum effect to tissue at the source. Further, the centimeter wavelengths of microwaves preclude tight focusing and energy placement in tissue.

The lack of both a high degree of spatial control and precision necessitates an alternative treatment methods and systems.

SUMMARY

A method and system for acoustic treatment of tissue are provided. Acoustic energy, including ultrasound, under proper functional control can penetrate deeply and be controlled precisely in tissue, in various embodiments, methods and systems can be configured for acoustic energy deposition into tissue based on creating an energy distribution function, in various embodiments, methods and systems can be configured based on creating a temperature distribution function in a medium.

Some embodiments provide an acoustic treatment system configured for temporarily or permanently affecting tissue or its physiology. The acoustic treatment system can comprise an energy source configured for delivery of acoustic or other energy to provide a treatment function in a region of interest; a control system for facilitating control of the energy source; and a set of functions, f(x,y,z,t), ire communication with the control system and defining a spatio-temporal distribution of the energy to provide the treatment function in the region of interest,

Some embodiments provide a method for providing acoustic treatment of tissue, The method can comprise localizing a region of interest; computing a spatio-temporal treatment function, e(x,y,z,t); delivering acoustic energy from an energy source into the region of interest; controlling the delivering acoustic energy with the spatiotemporal treatment function, e(x,y,z,t); producing at least one treatment function in the region of interest with the delivering acoustic energy. The method can further comprise monitoring of results of the treatment function before and/or during and/or after of the delivery of acoustic energy, The method can further comprise planning of additional treatment,

Some embodiments provide a method for providing acoustic treatment of tissue. The method can comprise identifying at least one region of interest; computing a spatio-temporal treatment function, e(x,y,z,t); delivering acoustic energy from an energy source into the region of interest; controlling the delivering acoustic energy with the spatio-temporal treatment function, e(x,y,z,t); producing desired temperature function, T(x,y,z,t) in the at least one region of interest with the delivering acoustic energy. The method can further comprise monitoring a temperature of the desired temperature function, T(x,y,z,t) in the at (east one region of interest, The method can further comprise adjusting the delivering acoustic energy to maintain the desired temperature function, T(x,y,z,t) in the at least one region of interest. The method can further comprise monitoring of results of the acoustic tissue treatment during and/or after the delivering acoustic energy, The method can further comprise continue planning of treatment based on the results. The method can comprise providing at least one bio-effect in the in the at least one region of interest. The method can comprise destroying tissue in the at least one region of interest. The method can further comprise generating at least one bio-effect in tissue proximate to the at least one region of interest.

DRAWINGS

The present disclosure will become more fully understood from the description and the accompanying drawings, wherein:

FIG. 1 is a block diagram illustrating an acoustic treatment system in accordance with various non-limiting embodiments;

FIG. 2 is a block diagram illustrating an acoustic treatment system in accordance with various non-limiting embodiments;

FIG. 3 is a block diagram illustrating an acoustic treatment system in accordance with various non-limiting embodiments;

FIG. 4 is a block diagram illustrating an acoustic treatment system in accordance with various embodiments;

FIG. 5 is a block diagram illustrating an acoustic treatment system in accordance with various non-limiting embodiments;

FIG. 6 is a set of graphs illustrating various spatial acoustic functions in accordance with various non-limiting embodiments;

FIG. 7 is a set of graphs illustrating various temporal acoustic functions in accordance with various non-limiting embodiments;

FIG. 8 is a graph illustrating a spatial temperature function in accordance with various non-limiting embodiments;

FIG. 9 is a graph illustrating a spatial temperature function in accordance with various non-limiting embodiments; and

FIG. 10 is a graph illustrating a spatial temperature function in accordance with various non-limiting embodiments.

DESCRIPTION

The following description is merely exemplary in nature and is in no way intended to limit the various embodiments, their application, or uses. As used herein, the phrase “at least one of A, B, and C” should be construed to mean a logical (A or B or C), using a non.-exclusive logical “or,” As used herein, the phrase “A, B and/or C” should be construed to mean (A, B, and C) or alternatively (A or B or C), using a non-exclusive logical “or.” It should be understood that steps within a method may be executed in different order without altering the principles of the present disclosure.

The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of any of the various embodiments disclosed herein or any equivalents thereof. It is understood that the drawings are not drawn to scale. For purposes of clarity, the same reference numbers will be used in the drawings to identify similar elements.

The various embodiments may be described herein in terms of various functional components and processing steps. It should be appreciated that such components and steps may be realized by any number of hardware components configured to perform the specified functions, For example, various embodiments may employ various medical treatment devices, visual imaging and display devices, input terminals and the like, which may carry out a variety of functions under the control of one or more control systems or other control devices. In addition, the embodiments may be practiced in any number of medical contexts and that the various embodiments relating to a method and system for acoustic tissue treatment as described herein are merely indicative of various examples of applications for the invention. For example, the principles, features and methods discussed may be applied to any medical application. Further, various aspects of the various embodiments may be suitably applied to cosmetic applications. Moreover, some of the embodiments may be applied to cosmetic enhancement of skin and/or various subcutaneous tissue layers.

Various embodiments can include energy source which is controlled via spatial and temporal parameters that are programmable to create predictable thermal field distribution, in various embodiments, system can comprise an energy source, which can be controlled by an acoustic energy function, In some embodiments, acoustic energy function provides parameters for spatial parameters and temporal parameters of energy source. Energy source provides energy into a medium that comprises a region of interest (“ROI”). In some embodiments, the acoustic energy function controls an energy emission from energy source into a targeted portion of the medium. In some embodiments, the targeted portion of the medium is the region of interest.

Medium can be any solid, liquid, gas or combinations thereof Medium cannot be a vacuum, In various embodiments, the medium is homogenous. In various embodiments, thermal resistance (thermal conductivity) and thermal capacity (specific heat) is at least one fixed or constant or linear. In various embodiments, the medium is in a closed system, In some embodiments, medium is soft tissue. In some embodiments, medium comprises at least one of subcutaneous tissue and a surface above the subcutaneous tissue.

The acoustic energy function controls an energy emission distribution that is deposited into ROI. In some embodiments, the acoustic energy function provides precise spatial and temporal control of acoustic enemy deposition. Accordingly, control of the energy source is confined within selected time and space parameters, with such control being independent of the medium,

In various embodiments, the interaction of the energy emission distribution with the medium creates a thermal energy distribution in the ROI. In various embodiments, the thermal energy distribution is defined by a temperature function, which has four dimensions, x, y, z, and t, where t is time at which a temperature is measured at coordinates x, y, and z. The thermal energy distribution is time dependent. The thermal energy distribution can be a conformal volume of deposition of thermal energy, The thermal energy distribution is a volume in the medium, having three dimensions x, y, and z. A boundary of distribution defines the thermal energy distribution within the boundary and the medium outside the boundary. The boundary of distribution is transparent to thermal energy if thermal capacity of medium is constant. The boundary of distribution is definable and thus is selectable by system. Since boundary of distribution is definable, energy source as programmable and/or controlled by acoustic energy function can provide a conformal energy emission distribution to create the thermal energy distribution within the defined boundary in the ROI.

In various embodiments, the thermal distribution field interacts with the medium to create an effect, Different thermal distribution fields create different temperature levels in the medium. The effect created in the medium is dependent on the temperature levels in the medium. In various embodiments, the effect can be one of but limited to ablation, cavitation, a resonance effect, or mechanical energy. In some embodiments, the thermal energy distribution creates a conformal elevated temperature distribution.

Typically, ultrasound energy propagates as a wave with relatively little scattering, over depths up to many centimeters in tissue depending on the ultrasound frequency. The focal spot size achievable with any propagating wave energy depends on wavelength. Ultrasound wavelength is equal to the acoustic velocity divided by the ultrasound frequency. Attenuation (absorption, mainly) of ultrasound by medium also depends on frequency, Shaped conformal distribution of elevated temperature can be created through adjustment of the strength, depth, and type of focusing, energy, levels and timing cadence. For example, focused ultrasound can be used to create precise arrays of microscopic thermal ablation zones. Ultrasound energy can produce an array of ablation zones deep into the medium, such as for example, layers of the soft tissue. Detection of changes in the reflection of ultrasound energy can be used for feedback control to detect a desired effect on the medium and used to control the exposure intensity, time, and/or position.

In various embodiments, energy source can be configured with the ability to controllably produce conformal distribution of elevated temperature in medium within a ROI through precise spatial and temporal control of acoustic energy deposition, i.e., control of ultrasound probe is confined within selected time and space parameters, with such control being independent of the medium. The ultrasound energy can be controlled using spatial parameters. The ultrasound energy can be controlled using temporal parameters. The ultrasound energy can be controlled using a combination of temporal parameters and spatial parameters.

In accordance with various embodiments, control system and energy source can be configured for spatial control of ultrasound energy by controlling the manner of distribution of the ultrasound energy. For example, spatial control may be realized through selection of the type of one or more transducer configurations insonifying ROI, selection of the placement and location of energy source for delivery of ultrasound energy relative to ROI e.g., energy source being configured for scanning over part or whole of ROI to produce contiguous thermal effect having a particular orientation or otherwise change in distance from ROI, and/or control of other environment parameters, e.g., the temperature at the acoustic coupling interface can be controlled, and/or the coupling of energy source to tissue. Other spatial control can include but are not limited to geometry configuration of energy source or transducer assembly, lens, variable focusing devices, variable focusing lens, stand-offs, movement of ultrasound probe, in any of six degrees of motion, transducer backing, matching layers, number of transduction elements in transducer, number of electrodes, or combinations thereof.

In various embodiments, control system and energy source can also be configured for temporal control, such as through adjustment and optimization of drive amplitude levels, frequency, waveform selections, e.g., the types of pulses, bursts or continuous waveforms, and timing sequences and other energy drive characteristics to control thermal ablation of tissue, Other temporal control can include but are not limited to fill power burst of energy, shape of burst, timing of energy bursts, such as, pulse rate duration, continuous, delays, etc., change of frequency of burst, burst amplitude, phase, apodization, energy level, or combinations thereof.

The spatial and/or temporal control Can also be facilitated through open-loop and closed-loop feedback arrangements, such as through the monitoring of various spatial and temporal characteristics. As a result, control of acoustical energy within six degrees of freedom, e.g., spatially within the X, Y and Z domain, as well as the axis of rotation within the XY, YZ and XZ domains, can be suitably achieved to generate conformal distribution of elevated temperature of variable shape, size and orientation. For example, through such spatial and/or temporal control, energy source can enable the regions of elevated temperature distribution possess controlled that is based on the function.

In some embodiments, the ultrasound energy may be unfocused and deposited in a volume that spans from the surface of the medium into a portion of the medium below. The ultrasound energy can have any of the characteristics as described herein. The ultrasound energy can be controlled using spatial parameters, The ultrasound energy can be controlled using temporal parameters. The ultrasound energy can be controlled using a combination of temporal parameters and spatial parameters.

Since temperature in a targeted portion of a region of interest is proportional to an intensity of acoustic energy that is delivered, various embodiments provide controlling a delivery acoustic energy into a region of interest using a distribution function, which exceeds a thermal capacity of tissue in the region of interest. Some embodiments provide controlling a delivery acoustic energy into a region of interest using a distribution function, which exceeds a threshold of cell death in a targeted portion of the region of interest. Various embodiments provide controlling a delivery, acoustic energy into a region of interest using a distribution function, Which does not exceed a thermal capacity of tissue in the region of interest, Various embodiments provide controlling a delivery acoustic energy into a region of interest with a step function,

A method and system for acoustic treatment of tissue are provided. Acoustic energy, including ultrasound, under proper functional control can penetrate deeply and be controlled precisely in tissue, in various embodiments, methods and systems can be configured for acoustic energy deposition into tissue based on creating an energy distribution function. In various embodiments, methods and systems can be configured based on creating a temperature distribution function in a medium.

Some embodiments provide an acoustic treatment system configured for temporarily or permanently affecting tissue or its physiology. The acoustic treatment system can comprise an energy source configured for delivery of acoustic or other energy to provide a treatment function to a region of interest; a control system for facilitating control of the energy source; and a set of functions, f(x,y,z,t), in communication with the control system and defining a spatio-temporal distribution of the energy to provide the treatment function in the region of interest,

In some embodiments, the set of functions, f(x,y,z,t), controls the thermal distribution of the acoustic energy delivered to the region of interest to provide the treatment function, in some embodiments, the set of functions, f(x,y,z,t), creates a desired temperature function in the region of interest.

In some embodiments, the system can further comprise an imaging function configured to image region of interest. In some embodiments, the system can further comprise a second energy source configured to deliver energy to provide the treatment function in the region of interest. In some embodiments, the second energy source is one a photon-based energy source, a RF energy source, and a microwave energy source.

In some embodiments, the method can further comprise monitoring of results of the treatment function during the delivery of acoustic energy. In some embodiments, the method can further comprise monitoring of results of the acoustic tissue treatment after the delivery of acoustic energy. In some embodiments, the method can further comprise planning of additional treatment.

In some embodiments, the function treatment initiates at less one thermal effect in the region of interest. In some embodiments, the at least one thermal effect is one of heating the region of interest, or creating a conformal region of elevated temperature in the region of interest. In some embodiments, the thermal effect is one of lesion creation in the region of interest, tissue necrosis in a portion of the region of interest; coagulation tissue in the treatment region, or exceeding a thermal capacity of tissue in a portion of the region of interest, and combinations thereof.

In some embodiments, the treatment function initiates at least one mechanical effect in the region of interest, In some embodiments, the at least one mechanical effect is at least one of cavitation, vibration, hydrodynamic, resonance-induced, streaming, vibro-accoustic stimulation, a pressure gradient and combinations thereof.

Various embodiments provide a method for providing acoustic treatment of tissue. The method can comprise localizing a region of interest; computing a spatio-temporal treatment function, e(x,y,z,t); delivering acoustic energy from an energy source into the region of interest; controlling the delivering acoustic energy with the spatio-temporal treatment function, e(x,y,z,t); producing at least one treatment function in the region of interest with the delivering acoustic energy. In some embodiments, the method can further comprise monitoring of results of the treatment function during and/or after of the delivery of acoustic energy. The method can further comprise planning of additional treatment.

Various embodiments provide a method for providing acoustic treatment of tissue. In some embodiments, the method can comprise identifying at least one region of interest; computing a spatio-temporal treatment function, e(x,y,z,t); delivering acoustic energy from an energy source into the region of interest; controlling the delivering acoustic energy with the spatiotemporal treatment function, e(x,y,z,t), producing desired temperature function, T(x,y,z,t) in the at least one region of interest with the delivering acoustic energy. In some embodiments, the method can further comprise monitoring a temperature of the desired temperature function, T(x,y,z,t) in the at least one region of interest. The method can further comprise adjusting the delivering acoustic energy to maintain the desired temperature function, T(x,y,z,t) in the at least one region of interest.

In some embodiments, the method can further comprise monitoring of results of the acoustic tissue treatment during and/or after the delivering acoustic energy. The method can further comprise continue planning of treatment based on the results. The method can comprise providing at least one bio-effect in the in the at least one region of interest. The method can comprise destroying tissue in the at least one region of interest. The method can further comprise generating at least one bio-effect in tissue proximate to the at least one region of interest.

In some embodiments, the method can further comprise monitoring a temperature of the desired temperature function, T(x,y,z,t) in the at least one region of interest. In some embodiments, the method can further comprise adjusting the delivering acoustic energy to maintain the desired temperature function, T(x,y,z,t) in the at least one region of interest. In some embodiments, the method can further comprise monitoring of results of the acoustic tissue treatment during and/or after the delivering acoustic energy.

In some embodiments, the method can further comprise providing at least one biological effect in the in the at least one region of interest based in the temperature function. In some embodiments, the at least one biological effect is destroying tissue in the at least a portion of the region of interest.

In some embodiments, the method can further comprise generating at least one biological effect in tissue proximate to the at least one region of interest based in the temperature function. In some embodiments, the method can further comprise delivering a photon-based energy into the region of interest and imitating a treatment effect in the region of interest. In some embodiments, the method can further comprise delivering a radio frequency based energy into the region of interest and imitating a treatment effect in the region of interest.

With reference to FIG. 1, a method of acoustic tissue treatment is illustrated. In various embodiments, acoustic tissue treatment method can comprise disposing an energy source 102 in a source region 104, delivering energy 115 through potential surfaces 110 into a region of interest 108, and creating a space-time acoustic energy function 112 in a targeted region of interest 106. In some embodiments, energy source 102 is an acoustic energy source delivering acoustic energy 115 to targeted region of interest 106. In some embodiments, energy source 102 is a combination of an acoustic energy source with at least one other energy source and is configured to deliver acoustic energy and at least one other energy to at least one of targeted region of interest 106 and source region 104, including subtraction of energy, e.g. via cooling.

In various embodiments, acoustic energy 115 propagates to or from energy source 102, including the form of communications energy. In various embodiments, energy source 102 is configured to emit ultrasound energy. In various embodiments, the acoustic energy function 112 can be an algebraic, geometric, convolution, or other mathematical combinations of one or more of the same or different functions for the same or different energy source or sources 102. For example, acoustic energy function 112 can be defined as a function, f, of time, t, as well as space, represented by the three orthogonal axes x, y, and z, such that the energy distribution, e, can be represented compactly in a mathematical notation as e=f(x, y, z, t). In various embodiments, acoustic energy function 112 controls energy source 102 to create targeted region of interest 106, which in some embodiments is a thermal energy distribution. In some embodiments, a targeted region of interest 106 is a voxel.

Potential surfaces 110, such as a tissue surface, may or may not exist between the energy source 102 and targeted region of interest 106, and in such cases the energy source 102 which lies within the source region 104 is also within the region of interest 108. In some embodiments, acoustic tissue treatment method is limited to a method of cosmetic enhancement, as described herein.

In various embodiments, acoustic energy function 112 creates a mechanical effect in targeted region of interest 106, For example, a mechanical effect can be cavitation, vibration, hydrodynamic, resonance-induced, streaming, vibro-accoustic stimulation, or a pressure gradient or combinations thereof. In various embodiments, acoustic energy function 112 creates an ablative effect in targeted region of interest 106. For example, an ablative effect can be lesion creation, tissue necrosis, coagulation, or exceeding a thermal capacity of tissue, or combinations thereof. In various embodiments, acoustic energy function 112 creates a thermal effect in targeted region of interest 106.

For example, a thermal effect can be heating subcutaneous tissue, creating a conformal region of elevated temperature distribution, or creating conformal region of elevated temperature distribution and a second conformal region of elevated temperature distribution, or combinations thereof. Shaped conformal distribution of elevated temperature can be created through adjustment of the strength, depth, and type of focusing, energy levels and timing cadence.

In various embodiments, acoustic energy function 112 can trigger (initiate and/or stimulate) one or more biological effects in targeted region of interest 106, A biological effect can be stimulating or increase an amount of heat shock proteins. Such a biological effect can cause white blood cells to promote healing of a portion of subcutaneous tissue in targeted region of interest 106. A biological effect can be to restart or accelerate the wound healing cascade in targeted region of interest 106 and/or in tissue proximate thereto. A biological effect can be increasing the blood perfusion in targeted region of interest 106 and/or in tissue proximate thereto. A biological effect can be encouraging collagen growth. A biological effect may increase the liberation of cytokines and may produce reactive changes in targeted region of interest 106 and/or in tissue proximate thereto. A biological effect may by peaking inflammation in region of interest 106 and/or in tissue proximate thereto, A biological effect may at least partially shrinking collagen portion in region of interest 106 and/or in tissue proximate thereto. A biological effect may be denaturing of proteins in targeted region of interest 106 and/or in tissue proximate thereto.

A biological effect may be creating immediate or delayed cell death (apoptosis) in targeted function region 106 and/or in tissue proximate thereto. A biological effect may be collagen remodeling in targeted region of interest 106 and/or in tissue proximate thereto. A biological effect may be the disruption or modification of biochemical cascades. A biological effect may be the production of new collagen.

A biological effect may a stimulation of cell growth in targeted region of interest 106 and/or in tissue proximate thereto, A biological effect may be angiogenesis. A biological effect may a cell permeability response. A biological effect may be an enhanced delivery of medicants to targeted region of interest 106 and/or to tissue proximate thereto.

In various embodiments, acoustic energy function 112 can initiate and/or stimulate one or more biological responses in targeted region of interest 106, such as, for example, diathermy, hemostasis, revascularization, angiogenesis, growth of interconnective tissue, tissue reformation, ablation of existing tissue, protein synthesis and/or enhanced cell permeability,

Furthermore, various embodiments provide energy, which may be a first energy and a second energy. For example, a first energy may be followed by a second energy, either immediately or after a delay period. In another example, a first energy and a second energy can be delivered simultaneously. In some embodiments, the first energy and the second energy is ultrasound energy. In some embodiments, the first energy is ultrasound and the second energy is generated by one of a laser, an intense pulsed light, a light emitting diode, a radiofrequency generator, photon-based energy source, plasma source, a magnetic resonance source, or a mechanical energy source, such as for example, pressure, either positive or negative. In other embodiments, energy may be a first energy, a second energy, and a third energy, emitted simultaneously or with a time delay or a combination thereof. In some embodiments, energy may be a first energy, a second energy, a third energy, and an nth energy, emitted simultaneously or with a time delay or a combination thereof Any of the a first energy, a second energy, a third energy, and a nth nay be generated by at least one of a laser, an intense pulsed light, a light emitting diode, a radiofrequency generator, an acoustic source, photon-based energy source, plasma source, a magnetic resonance source, and/or a mechanical energy source. In various embodiments, a second energy can be control by a second energy function. In some embodiments, a second thermal energy distribution is created by second energy source. In some embodiments, the thermal energy distribution and the second thermal energy distribution can be combined.

With reference to FIG. 2 and according to various embodiments, an acoustic treatment system 200, can comprise acoustic energy source 102 coupled either wirelessly or wired to control system 103. In some embodiments, acoustic treatment system 2.00 can be configured whereby control system 103 and all control thereof is embedded in acoustic energy source 102, such as for example, system 200 being configured as a hand-held device. In some embodiments, acoustic energy source 102 and control system 103 are integrated into one unit, Control for control system 103 is exerted on acoustic energy source 102 to create a desired acoustic energy function 112 in targeted region of interest 106. In some embodiments, acoustic energy function 112 creates a desired temperature function in tissue. Acoustic energy source 102 can be controlled in terms of geometry, output power amplitude and timing and spatial distribution of source energy 115.

In various embodiments, acoustic treatment system 200 can comprise energy source 102 configured for delivery of acoustic or other energy 115 to targeted region of interest 106, control system 103 for facilitating control of the energy source 102 and acoustic energy function 112, such as, for example, a set of functions, f(x,y,z,t), in communication with control system 103 and defining a spatiotemporal distribution of the energy 115 in targeted region of interest 106.

In various embodiments, acoustic energy system 200 is an entire system capable of at least one of treating, imaging, or monitoring, before, during and after treatment, using at least one of acoustic energy and any other energy source, including for example laser, photon emission, and/or radio frequency energy. In some embodiments, acoustic energy system 200 comprises acoustic energy source 102, control system 103, and at least one other energy source, all encompassed in one unit.

Various embodiments provide a method for providing acoustic treatment of tissue. The method can comprise localizing a region of interest 108, computing a spatio-temporal treatment function, e(x,y,z,t), delivering acoustic energy 115 from an energy source 102 into the region of interest 108, controlling the delivering acoustic energy 115 with the spatio-temporal treatment function, e(x,y,z,), producing at least one treatment function 106 in the region of interest 108 with the delivering acoustic energy 115, The method can further comprise monitoring of results of the acoustic tissue treatment during and/or after of the delivery of acoustic energy 115, The method can further comprise planning of additional treatment, In some embodiments, the method is a method of cosmetic enhancement.

Various embodiments provide a method for providing acoustic treatment of tissue, The method can comprise identifying at least one region of interest 108, computing a spatio-temporal treatment function, e(x,y,z,t), delivering acoustic energy 115 from an energy source 102. into the region of interest 108, controlling the delivering acoustic energy 115 with the spatia-temporal treatment function, e(x,y,z,t), producing desired temperature function, T(x,y,z,t) in the at least one region of interest 108 with the delivering acoustic energy 115, The method can further comprise monitoring a temperature of the desired temperature function, T(x,y,z,t) in the at least one region of interest 108. The method can further comprise adjusting the delivering acoustic energy 115 to maintain the desired temperature function, T(x,y,z,t) in the at least one region of interest 108. The method can further comprise monitoring of results of the acoustic tissue treatment during and/or after the delivering acoustic energy 115. The method can further comprise continue planning of treatment based on the results. The method can comprise providing at least one bio-effect in the in the at least one region of interest 108. The method can comprise destroying tissue in the at least one region of interest 108. The method can further comprise generating at least one biological effect in tissue proximate to the at least one region of interest 108. in some embodiments, the method is method of cosmetic enhancement.

Moving to FIG. 3, in some embodiments the acoustic energy source 102 is controlled to produce a specific acoustic energy function 340, e=a(t) [u(x−x₁)−u(x−x₂)] [u(y−y₁)−u(y−y₂)] [u(z−z₁)−u(z−z₂)] g(x, y, z), where u(γ) is the step function 330, a(t) represents the time excitation, and g(x, y, z) represent the spatial modulation within the regions bound by [x₁, x₂], [y₁, y₂], and [z₁, z₂] along the axes 320. Control of one or more parameters of the specific acoustic energy function 340, defines the explicit shape of the targeted region of interest 106 to affect acoustic tissue treatment. As will be apparent to those of ordinary skill in the art, acoustic energy function 340 is a subset of acoustic energy function 112 and can be employed in any method and/or system described herein.

Specifically with respect to FIG. 4, in some embodiments, a specific acoustic energy function 440, e=a(t) u(z−z₁) g(x, y, z), is created by the energy source 106 whereby an axial step function of energy is placed beginning at a depth z₁ to define the acoustic targeted region of interest 106. This step function is further modulated by the spatial distribution g(x, y, z), and further defined by the temporal characteristic of excitation, a(t). In some embodiments, acoustic energy source 102 is controlled to achieve the desired specific acoustic energy function 440, which can produce a step change in temperature at depth z₁. Furthermore, acoustic energy source 102 can be controlled to achieve the desired specific acoustic energy function 440, which can produce a step change in temperature at a second depth (not shown in FIG. 4). As will be apparent to those of ordinary skill in the art acoustic energy function 440 is a subset of acoustic energy function 112 and can be employed in any method and/or system described herein.

It should be appreciated that designated conformal volume spatially and temporally controlled by functions described as a specific acoustic energy function. 440, e=a(t) u(z−z₁) g(x, y, z), could be expanded in one or more conformal volumes. Such effect will produce one or more distinct zones of controlled and predictable parameters and dimensions by either electronic and/or mechanical. displacements of the acoustic energy source, 102. Further, the acoustic energy source 102 may be programmable to perform predictable and/or repeatable spatial and temporal energy transduction with or without feedback from a variety of monitoring parameters, such as tissue parameters, pressure, amplitude, energy absorption, and attenuation, to name a few.

In some embodiments as shown in FIG. 5, a specific acoustic energy function 540, defined by e=a(t) δ(x−x₀) δ(y−y₀) δ(z−z₀) g(x, y, z), where δ(γ) is a delta function 530, is created by controlling energy source 102, to produce an energy impulse at a location (x₀, y₀, z₀) in the targeted tissue region 106. This specific acoustic energy function is further modulated by the spatial distribution g(x, y, z), and further defined by the temporal characteristic of excitation, a(t). In some embodiments, the function produces an impulse change in temperature at position (x₀, y₀, z₀). As noted, in various embodiments the specific acoustic energy function 540 can be an algebraic, geometric, or convolution combination of one or more of the same or different functions for the same or different energy source or sources 102, As will be apparent to those of ordinary skill in the art, acoustic energy function 540 is a subset of acoustic energy function 112 and can be employed in any method and/or system described herein.

In various embodiments as shown in FIG. 6, a plurality of functions as defined by acoustic energy functions 612, e( x, y, z, t). In the spatial domain, γ represents a subset of, and substitution of variable for, one or more of the set of coordinates {x, y, z}. One of the plurality of functions is an impulse function 650. One of the plurality of functions is a step or square (two step) function 651. One of the plurality of functions is a fast-attack slow-decay (or slow-attack fast-decay) function 652. One of the plurality of functions is a ramp 653. One of the plurality of functions is a harmonic or sinusoidal function 654. One of the plurality of functions is a collection of impulses in space 655. Any one of these plurality of treatment functions can be disposed anywhere in the region of interest to produce an effect on tissue, as described herein. As will be apparent to those of ordinary skill in the art, acoustic energy functions 612 are a subset of acoustic energy function 112 and can be employed in any method and/or system described herein.

In various embodiments as shown in FIG. 7, a plurality of functions as defined by functions 712, namely e(x, y, z, t). One of the plurality of functions in the time domain is an impulse function 750. One of the plurality of functions in the time domain is a step or square (two step) function 751. One of the plurality of functions in the time domain is a fast-attack slow-decay (or slow-attack fast-decay) function 752. One of the plurality of functions in the time domain is a harmonic or sinusoidal burst function 753. One of the plurality of functions in the time domain is a ramp 754. One of the plurality of functions in the time domain is a collection of time samples or impulses in space 755. Any one of these plurality of treatment functions can be disposed anywhere in the region of interest to produce an effect on tissue, as described herein. As will be apparent to those of ordinary skill in the art, acoustic energy functions 712 are a subset of acoustic energy function 112 and can be employed in any method and/or system described herein.

Moving to FIG. 8, a graph illustrates a temperature distribution function versus the spatial parameter which again represents a subset of, and substitution of variable for, one or more of the set of coordinates {x, y, z}. In various embodiments, temperature distribution 860, such as a fast-attack temperature distribution, is disposed in space axially and or laterally and can be modified by algebraic, geometric, convolutional, or other mathematical combinations thereof. Control of energy sources, e.g. cooling and or parametric control, can be used to change the position of any temperature distribution function in space to a proximal temperature distribution 862 or distal temperature distribution 864.

Turning to FIG. 9, a graph illustrates a temperature distribution function versus the spatial parameter γ which again represents a subset of, and substitution of variable for, one or more of the set of coordinates {x, y, z}. In various embodiments, temperature distribution 960, such as a square step or two-step temperature distribution, is disposed in space axially and or laterally and can be modified by algebraic, geometric, convolutional, or other mathematical combinations thereof for acoustic tissue treatment,

Now with reference to FIG. 10, a graph illustrates a temperature distribution function versus the spatial parameter γ which again represents a subset of, and substitution of variable for, one or more of the set of coordinates {x, y, z}. Temperature distribution 1060, such as an impulse temperature distribution, is disposed in space axially and or laterally and can be modified by algebraic, geometric, convolutional, or other mathematical combinations thereof for acoustic tissue treatment, Such algebraic combination is shown as 1062.

The following patents and patent applications are incorporated by reference: US Patent Application Publication No. 20050256406, entitled “Method and System for Controlled Scanning, Imaging, and/or Therapy” published Nov. 17, 2005; US Patent Application Publication No. 20060058664, entitled “System and Method for Variable Depth Ultrasound Treatment” published Mar. 16, 2006; US Patent Application Publication No. 20060084891, entitled Method and System for Ultra-High Frequency Ultrasound Treatment” published Apr. 20, 2006; U.S. Pat. No. 7,530,958, entitled “Method and System for Combined Ultrasound Treatment” issued May 12, 2009; US Patent Application Publication No. 2008071255, entitled “Method and System for Treating Muscle, Tendon, Ligament, and Cartilage Tissue” published Mar. 20, 2008; U.S. Pat. No. 6,623,430, entitled “Method and Apparatus for Safely Delivering Medicants to a Region of Tissue Using Imaging, Therapy, and Temperature Monitoring Ultrasonic System, issued Sep. 23, 2003; U.S. Pat. No. 7,571,336, entitled “Method and System for Enhancing Safety with Medical Peripheral Device by Monitoring if Host Computer is AC Powered” issued Aug. 4, 2009; US Patent Application Publication No. 20080281255, entitled “Methods and Systems for Modulating Medicants Using Acoustic Energy” published Nov. 13, 2008; US Patent Application Publication No. 20060116671, entitled “Method and System for Controlled Thermal Injury of Human Superficial Tissue,” published Jun. 1, 2006; US Patent Application Publication No. 20060111744, entitled “Method and System for Treatment of Sweat Glands,” published May 25, 2006; US Patent Application Publication No, 20080294073, entitled “Method and System for Non-Ablative Acne Treatment and Prevention, ” published Oct. 8, 2009; U.S. Pat. No. 8,133,180, entitled “Method and System for Treating Cellulite,” issued Mar. 13, 2012; U.S. Pat. No. 8,066,641, entitled “Method and System for Photoaged Tissue,” issued Nov. 29, 2011; U.S. Pat. No. 7,491,171, entitled “Method and System for Treating Acne and Sebaceous Glands,” issued Feb. 17, 2009; U.S. Pat. No. 7,615,016, entitled “Method and System for Treating Stretch Marks,” issued Nov. 10, 2009; and U.S. Pat. No. 7,530,356, entitled “Method and System for Noninvasive Mastopexy,” issued May 12, 2009.

The present invention has been described above with reference to various exemplary embodiments. However, those skilled in the art will recognize that changes and modifications may be made to the exemplary embodiments without departing from the scope of the present invention. For example, the various operational steps, as well as the components for carrying out the operational steps, may be implemented in alternate ways depending upon the particular application or in consideration of any number of cost functions associated with the operation of the system, e.g., various of the steps may be deleted, modified, or combined with other steps, Further, it should be noted that while the method and system for ultrasound treatment as described above is suitable for use by a medical practitioner proximate the patient, the system can also be accessed remotely, i.e., the medical practitioner can view through a remote display having imaging information transmitted in various manners of communication, such as by satellite/wireless or by wired connections such as IP or digital cable networks and the like, and can direct a local practitioner as to the suitable placement for the transducer, Moreover, while the various exemplary embodiments may comprise non-invasive configurations, system can also be configured for at least some level of invasive treatment application, These and other changes or modifications are intended to be included within the scope of the present invention, as set forth in the following claims.

It is believed that the disclosure set forth above encompasses at least one distinct invention with independent utility. While the invention has been disclosed herein, the specific embodiments thereof as disclosed and illustrated herein are not to be considered in a limiting sense as numerous variations are possible, The subject matter of the inventions includes all novel and non-obvious combinations and sub combinations of the various elements, features, functions and/or properties disclosed herein.

Various embodiments and the examples described herein are not intended to be limiting in describing the full scope of systems and methods of this invention, Equivalent changes, modifications and variations of various embodiments, materials, systems, and methods may be made within the scope of the present invention, with substantially similar results, 

1-24. (canceled)
 25. A method for providing acoustic treatment of soft tissue within a patient, said method comprising: a) localizing a region of interest in the soft tissue; b) computing, without feedback from monitoring parameters, a spatio-temporal treatment function, e(x,y,z,t) that produces a desired temperature function T(x,y,z,t) in the region of interest, the spatio-temporal treatment function e(x,y,z,t) defining an ultrasound intensity at the time t at distinct locations x,y,z in the region of interest, the computing the spatio-temporal treatment function including one or more step functions, u(γ), to define boundaries of the region of interest, a time excitation function, a(t), and a three-dimensional spatial modulation function, g(x,y,z); c) delivering acoustic energy from an energy source into the region of interest by controlling the energy source with spatial and temporal parameters derived from the spatio-temporal treatment function e(x,y,z,t), thereby producing the desired temperature function T(x,y,z,t) in the region of interest, thereby triggering an effect in the region of interest.
 26. The method according to claim 25, further comprising monitoring of results of the acoustic treatment during the delivery of acoustic energy.
 27. The method according to claim 25, further comprising monitoring of results of the acoustic treatment after the delivery of acoustic energy.
 28. The method according to claim 25, wherein the effect is coagulation of a portion of the tissue in the region of interest.
 29. The method according to claim 25, step c) thereby initiating tissue necrosis in the region of interest.
 30. The method according to claim 25, wherein the effect is creating a conformal region of elevated temperature in the region of interest.
 31. The method according to claim 25, wherein the effect is lesion creation in the region of interest.
 32. The method according to claim 25, wherein the effect is initiating at least one mechanical effect in the region of interest.
 33. The method according to claim 32, wherein the at least one mechanical effect is at least one of cavitation, resonance-induced streaming, vibroacoustic stimulation, a pressure gradient, and combinations thereof
 34. The method according to claim 25, wherein the spatio-temporal treatment function, e(x,y,z,t) is e=a(t) [u(x−x₁)−u(x−x₂)] [u(y−y₁)−u(y−y₂)] [u(z−z₁)−u(z−z₂)] g(x,y,z), where u(γ) is a step function, a(t) represents the time excitation, and g(x,y,z) represents the spatial modulation within the regions bound by [x₁, x₂], [y₁, y₂], and [z₁, z₂].
 35. The method according to claim 25, wherein the spatio-temporal treatment function, e(x,y,z,t) is e=a(t) u(z−z₁) g(x,y,z), where u(γ) is a step function of energy is placed beginning at a depth z₁ in the treatment function region, g(x,y,z) represents the spatial modulation within the treatment function region, and a(t) represents the time excitation.
 36. The method according to claim 35, wherein delivering acoustic energy produces a step change in temperature at the depth z₁ in the region of interest.
 37. A method for providing acoustic treatment of soft tissue within a patient, said method comprising: a) identifying a region of interest comprising the soft tissue; b) computing, without feedback from monitoring parameters, spatial and temporal parameters that, when used to control an energy source, produce a desired time-dependent thermal energy distribution in the region of interest the computing the spatial and temporal parameters including one or more step functions, u(γ), to define boundaries of the region of interest, a time excitation function, a(t), and a three-dimensional spatial modulation function, g(x,y,z); c) delivering acoustic energy from the energy source into the region of interest by controlling the energy source with the spatial and temporal parameters, thereby producing the desired time-dependent thermal energy distribution in the region of interest, thereby initiating an effect in the soft tissue.
 38. The method according to claim 37, further comprising monitoring a temperature of the desired time-dependent thermal energy distribution in the at least one region of interest.
 39. The method according to claim 37, further comprising monitoring of results of the acoustic treatment during and/or after the delivering acoustic energy.
 40. The method according to claim 37, wherein the desired thermal energy distribution initiates at least one biological effect in the region of interest.
 41. The method according to claim 40, wherein the at least one biological effect is destroying tissue in at least a portion of the region of interest.
 42. The method according to claim 37, wherein the desired thermal energy distribution generates at least one biological effect in a tissue proximate to the region of interest.
 43. The method according to claim 37, further comprising delivering a photon-based energy into the region of interest and initiating a second effect in the region of interest.
 44. The method according to claim 37, further comprising delivering a radio frequency based energy into the region of interest and initiating a second effect in the region of interest. 